Anxo Pharmaceutical (瑩碩生技) announced on the 29th that it has signed an exclusive licensing agreement with WhanIn Pharm. Co., Ltd., a top 50 South Korean pharmaceutical company, for its high-barrier oral generic drug MPH in the Korean market. Under the agreement, Anxo will receive upfront signing fees, milestone payments, and supply revenues after product launch, while WhanIn will handle local bioequivalence (BE) trials, regulatory approval, and commercialization.
Since no generic drug with the same active ingredient has yet been approved in South Korea and supply of the original patented product is unstable, MPH is expected to become the first generic on the Korean market, tapping into a market opportunity worth over tens of millions of U.S. dollars.
Anxo Pharmaceutical’s CEO Lin Yen-Chuan (顏麟權) explained that MPH is used to treat attention deficit hyperactivity disorder (ADHD) by increasing dopamine and norepinephrine levels in the brain, thereby improving attention and reducing hyperactivity and impulsivity. Commonly referred to as a “smart drug,” the original MPH patent has expired. Using its proprietary technology platform, Anxo has developed four extended-release dosages—18 mg, 27 mg, 36 mg, and 54 mg. Among them, the 18 mg and 36 mg products have obtained regulatory approval in Taiwan, and the 27 mg dosage is currently under review. With stable demand and sales in Taiwan, Anxo’s licensing of all four dosages to WhanIn reflects recognition of its technological capabilities and marks a strategic step to expand into overseas markets.
WhanIn Pharm., headquartered in Seoul, is a publicly listed South Korean company recognized as a market leader in the production and sales of central nervous system and psychiatric drugs.
According to South Korea’s Ministry of Food and Drug Safety (MFDS), the number of ADHD patients has increased steadily, with an average growth of 23.9% over the past five years. Student populations in particular are growing rapidly, driving increased demand for related therapies. MPH’s original brand recorded sales of approximately NT$600 million (US$22 million) last year, and to date, no generic drug with the same ingredient and formulation has been approved in South Korea.
Notably, since the second half of last year, the original brand has experienced supply disruptions, resulting in frequent shortages. Due to the limited effectiveness of alternative treatments and the high technical barrier requiring specialized production equipment, no competitors have yet entered development. This positions MPH to potentially capture a dominant market share upon successful launch.
Lin stated that Anxo, with multiple proprietary technology platforms, focuses on developing high-barrier, high-niche generic drugs. This licensing agreement represents another successful expansion into overseas markets and carries significant implications for future business growth. The MPH model in Korea could be replicated in other regions, providing new growth momentum for the company.
According to The Insight Partners, the global ADHD treatment market is projected at approximately US$31.42 billion in 2024. With increasing public awareness of ADHD and the emergence of new treatment options, the global ADHD drug market is expected to expand to US$66.27 billion by 2031, representing a compound annual growth rate of 10.8%.
Resource: 瑩碩過動症藥品授權韓商丸仁製藥 搶攻6億市場商機
